The reagent can be used as a positive control for the testing systems used to detect the presence of COVID-19. A positive control is included in tests by means of a sample that contains a known amount of the coronavirus genetic material. This acts as a confirmatory sample that assures the test is working correctly.
The reagent is non-infectious genetic material from SARS-CoV-2, the coronavirus responsible for the COVID-19 pandemic. An initial batch of 1,500 vials is available from the National Institute for Biological Standards and Control (NIBSC) with production of a further batch currently underway.
An expert centre of the MHRA, NIBSC has fast-tracked the development and production of this reagent. It is to be made freely available globally and will help more laboratories to respond to the COVID-19 pandemic.
Dr Nicola Rose, Head of the Division of Virology at the NIBSC, said:
Accurate diagnostic tests are a vital component in the fight against COVID-19.
This reagent is a great example of the NIBSC rapidly responding to public health needs in the response to COVID-19. The development of the research material is a prelude to the production of established standards and reference materials that laboratories can use in their own work on COVID-19, and we will continue to make producing this material an absolute priority.
Health Minister Lord Bethell said:
We have built the largest diagnostic testing industry in British history from scratch in a matter of weeks.
Thanks to our world-leading scientists and clinicians, we’ve now been able to fast-track a new biological reagent to help the UK and countries across the globe carry out even more tests and develop ever more accurate ways of diagnosing the virus.
“It’s yet another example of the UK’s pioneering life sciences sector leading the way in the fight against coronavirus.
The rapid availability of biological materials is a key component in global response efforts to tackle the COVID-19 outbreak. The availability of the reagent also supports the Government’s new national testing strategy, which involves testing in NHS and PHE laboratories, as well as in a completely new network of labs, mobile testing units and home testing kits across the UK, to boost testing capacity.
Additional SARS-CoV-2-related research materials are also available from the NIBSC.